The 340B Drug Pricing Program has been in effect for over twenty years, yet managed markets teams continue to face several challenges including Medicaid expansion, significant changes outlined in The Affordable Care Act and an evolving regulatory framework. To combat these regulatory challenges, the Health Resource & Service Administration (HRSA) previously announced they would reinforce existing guidance and issue a regulation which would narrow the reach of the drug discount program, termed the “mega-reg”. This guidance was scheduled to be released in 2014, but was officially pulled on November 13, 2014 in light of several legal challenges relating to other 340B regulations. While HRSA has stated they will issue new guidance on a broad range of 340B policy and practical issues in 2015, all stakeholders need to prepare for significant changes ahead.Anticipated 2015 HRSA guidance and implications

Current and future regulatory oversight of 340B

HRSA’s role in 340B governance

Related case and outcomes analysis

Speaker:John D. ShakowPartnerKing & Spalding

Participants that will find this webinar most beneficial will be those involved in pharmaceuticals companies. Job titles of attendees that will be most applicable for this session will be: